SEC Filings

The approval of the research is only for the specific researcher (that applied) and the medical institution, and cannot be transferred.

9.

It is forbidden to publish any information regarding the experiment in the mass media (newspaper, radio, tv, internet), however, it is allowed to publish the experiment in scientific journals/ conferences or in order to recruit participants.

10.

The supply of the experiment products, the storage of the products, and the way that the drugs are provided to the patients are the leading researcher’s responsibility. If there is a usage of drugs, it should be in accordance with the institution pharmacy, unless the Helsinki Committee approved otherwise.

11.

Every drug that is given to any participant in the experiment, will be provided by the hospital’s pharmacy, with a prescription stating the participant’s name. It is forbidden to accept drugs and give them to patients, directly from the supplier.

12.

If there is a need to file a request to the Ministry of Health to import a drug, this consent must be submitted as an exhibit.

13.

The person who will submit such request has the responsibility to keep this approval in his records.

14.

Every participant that is participating in the experiment, will receive a copy of his signed informed consent to participate in the experiment.

15.

The leading researcher will keep all the application documents for this experiment, that he filed with the Helsinki Committee and all the documents that were collected during the experiment, at least for a period of 15 years from the termination date of the experiment.

16.

This approval of the experiment, does not apply on soldiers. If there is a willingness to include a solider in the experiment, the IDF (The Israeli Army) must approve it.

17.

The doctor that is responsible for the experiment must notify the patient’s family doctor regarding the patient’s participation in the experiment and regarding the services that he is getting/ got in the experiment.

Best of luck,

Sincerely,

Professor Shlomo Mor Yosef

General Director

Hadassah Medical Organization

[ * ] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.